Recall Z-1708-2017 ยท DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Philips Visicu
eCare Coordinator Product Usage: is software intended for use in data aggregation, patient interaction facilitation, storage and clinical information management with independent physiological devices and ancillary systems that are connected either directly or through networks. The software is intended to provide patient information from the patient location through networking technology to a r
| Date | Mar 2, 2017 |
| Status | Terminated |
| Reason | eCareCoordinator (eCC) is intended for use in data aggregation, patient interaction facilitation, storage and clinical information management with independent physiological devices and ancillary systems that are connected either directly or through networks. The software is intended to provide patient information from the patient location through networking technology to a remote care team. A software defect was discovered in the Philips eCareCoordinator (eCC) Clinical User Interface that can at times cause missing or redundant data to be saved without notification to the user. |
| Root cause | Software Manufacturing/Software Deployment |
| Action | Field Safety Notice (FSN) will be sent to all customers using eCareCoordinator all Versions. The FSN describes the problem and circumstances in which the design defects occurs and the action planned by Philips to correct the problem. The FSN will also detail the functionality change in detail. A software correction will be made and released.by the vendor. Customers will have this correction applied to their current version when made available by Vendor in order to fix this correction. |
| Quantity | 26 |
| Distribution | Worldwide Distribution-US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141706 | ECARE COORDINATOR (ECC) Visicu, Inc., Sep 9, 2014 |